Vitamin D Retrospective Study and Role With Disease
Association of Vitamin D With Diabetes, Osteoporosis and Cardiovascular Risk
1 other identifier
observational
362
1 country
1
Brief Summary
Vitamin D deficiency is associated with a heightened risk for developing type 2 diabetes, hypertension, and osteopenia/osteoporosis. Vitamin D is made in the skin when it is exposed to sunlight and it is also obtained from the diet and dietary supplements. Older people, individuals with high skin pigmentation, obese and sedentary individuals have low levels of Vitamin D because pigmentation blocks Vitamin D production in the skin, aging and physical inactivity are associated with reduced exposure to sunlight, and obesity is associated with the storage of Vitamin D in fat preventing its utilization by muscle, bone and other tissues that require its metabolic action. These conditions are also associated with heightened risk for developing type 2 diabetes, glucose intolerance, hypertension, and osteopenia/osteoporosis in older and obese individuals. This is particularly heightened in older women who tend to have increased body fat, are more physically inactive and are at high risk for central obesity and its metabolic consequences of diabetes, hypertension and osteoporosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 21, 2013
CompletedFirst Posted
Study publicly available on registry
February 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJuly 20, 2021
July 1, 2021
12 years
February 21, 2013
July 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vitamin D
Vitamin D level ng/dl
Day 1
Other Outcomes (3)
IGF-1
Day 1
IGF binding proteins
Day 1
PTH
Day 1
Study Arms (1)
Vitamin D
Specimen analysis
Interventions
Eligibility Criteria
obese, older men and postmenopausal women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baltimore VAMC
Baltimore, Maryland, 21201, United States
Related Publications (1)
Sorkin JD, Vasaitis TS, Streeten E, Ryan AS, Goldberg AP. Evidence for threshold effects of 25-hydroxyvitamin D on glucose tolerance and insulin resistance in black and white obese postmenopausal women. J Nutr. 2014 May;144(5):734-42. doi: 10.3945/jn.114.190660. Epub 2014 Apr 9.
PMID: 24717362DERIVED
Biospecimen
Vitamin D, IGF-1, and PTH levels will be measured in coded plasma samples belonging to the PI and collaborating Investigators within the GRECC that are stored in our freezers (from previously approved studies: HP-00040261,HP-00040975, HP-00041166 and HP-00041199) . The Nutrition Obesity research center genetics core will determine Vitamin D receptor polymorphisms on de-identified samples. No clinical information will accompany the samples.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alice S Ryan, PhD
Baltimore VAMC
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 21, 2013
First Posted
February 25, 2013
Study Start
November 1, 2009
Primary Completion
November 1, 2021
Study Completion
December 1, 2022
Last Updated
July 20, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share